US12311170B2ActiveUtilityA1

Device and method for unattended treatment of a patient

Assignee: BTL HEALTHCARE TECHNOLOGIES ASPriority: May 4, 2020Filed: Jul 8, 2024Granted: May 27, 2025
Est. expiryMay 4, 2040(~13.8 yrs left)· nominal 20-yr term from priority
A61N 1/0492A61N 1/0452A61N 5/0616A61N 2007/0008A61N 2005/0642A61N 2007/0034A61N 1/328A61B 2018/00291A61N 7/00A61B 18/04A61B 2018/0016A61B 2018/00589A61B 2018/00577A61B 2018/00452A61B 2018/00321A61N 2005/0643A61N 1/36034
92
PatentIndex Score
1
Cited by
3,098
References
30
Claims

Abstract

An unattended approach can increase the reproducibility and safety of the treatment as the chance of over/under treating of a certain area is significantly decreased. On the other hand, unattended treatment of uneven or rugged areas can be challenging in terms of maintaining proper distance or contact with the treated tissue, mostly on areas which tend to differ from patient to patient (e.g. facial area). Delivering energy via a system of active elements embedded in a flexible pad adhesively attached to the skin offers a possible solution. The unattended approach may include delivering of multiple energies to enhance a visual appearance.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A device for a treatment of a patient, comprising:
 a radiofrequency generator configured to generate a radiofrequency energy; 
 a user interface configured to allow an operator of the device to select a treatment protocol; 
 a control unit configured to control the radiofrequency generator according to the treatment protocol selected by the operator; and 
 an applicator configured to be coupled to a body part of a patient, the body part comprising a face, a neck, or a submentum, the applicator comprising:
 a pad having a surface area in a range of 0.5 cm 2  to 100 cm 2  and configured to be attached to the body part during a treatment, the pad comprising:
 a flexible substrate comprising an underside configured to face the patient during the treatment; 
 an electrode coupled to the underside of the flexible substrate and configured to apply the radiofrequency energy to the body part to cause heating of the body part; and 
 an adhesive layer positioned below the electrode and configured to attach the electrode to the body part, 
 
 wherein a side of the electrode configured to face the body part is at least partially covered by the adhesive layer, and 
 wherein the electrode is configured to be in contact with the body part via the adhesive layer. 
 
 
     
     
       2. The device of  claim 1 , wherein the electrode has a surface area in a range of 0.1 cm 2  to 70 cm 2 . 
     
     
       3. The device of  claim 2 , wherein the applicator further comprises:
 a connector configured to couple the applicator with the radiofrequency generator and comprising a contact; and 
 a connecting part coupling the pad with the connector and comprising a conductive lead configured to couple the electrode with the contact. 
 
     
     
       4. The device of  claim 2 , wherein the control unit is configured to provide the radiofrequency energy in pulses. 
     
     
       5. The device of  claim 4 , wherein each radiofrequency pulse lasts for a duration in a range of 0.5 ms to 5 s. 
     
     
       6. The device of  claim 5 , wherein the each radiofrequency pulse has a rectangular envelope. 
     
     
       7. The device of  claim 6 , wherein a pause time, when there is no delivery of the radiofrequency energy, between two consecutive radiofrequency pulses is in the range of 500 us to 500 ms. 
     
     
       8. A method of treatment of a patient, comprising:
 generating a radiofrequency energy having a frequency in a range of 100 kHz to 550 MHz by a radiofrequency generator; 
 controlling the radiofrequency generator by a control unit; 
 attaching a pad having a surface area in a range of 0.5 cm 2  to 100 cm 2  to a body part of a patient during a treatment, the body part comprising a face, a neck, or a submentum, the pad comprising:
 a flexible substrate comprising an underside configured to face the patient during the treatment; 
 a plurality of electrodes comprising a first electrode and a second electrode coupled to the underside of the flexible substrate, 
 wherein a distance between the first electrode and the second electrode is in a range of 0.5 mm to 2 cm; and 
 an adhesive layer positioned below the first electrode and the second electrode and configured to attach the pad to the body part, 
 wherein a side of the first electrode configured to face the body part is at least partially covered by the adhesive layer, and 
 wherein the first electrode is configured to be in contact with the body part via the adhesive layer; 
 
 selecting a treatment protocol by an operator of the device via a user interface; and 
 providing the radiofrequency energy to the body part by the first electrode and the second electrode to cause heating of the body part according to the selected treatment protocol. 
 
     
     
       9. The method of  claim 8 , wherein the radiofrequency energy is generated with a frequency in a range of 400 kHz to 80 MHz. 
     
     
       10. The method of  claim 9 , further comprising attaching the pad to a forehead of the patient,
 wherein the plurality of electrodes comprises 2 to 20 electrodes. 
 
     
     
       11. The method of  claim 10 , wherein each electrode from the plurality of electrodes has a surface area in a range of 1 cm 2  to 10 cm 2 . 
     
     
       12. The method of  claim 11 , wherein the each electrode from the plurality of electrodes has a surface area in a range of 2 cm 2  to 6.5 cm 2 . 
     
     
       13. The method of  claim 10 , wherein the heating of the body part by the radiofrequency energy is provided in a range of 38° C. to 53° C. 
     
     
       14. The method of  claim 10 , further comprising providing an electrotherapy by:
 generating an electric current having a frequency in a range of 0.1 Hz to 12 kHz by an electric current generator, 
 controlling the electric current generator by the control unit, and 
 applying the electric current to the body part by the first electrode and the second electrode. 
 
     
     
       15. The method of  claim 14 , further comprising applying the electric current in pulses having a frequency in a range of 0.1 Hz to 6 kHz in order to provide relief of pain. 
     
     
       16. A method of a treatment of a patient, comprising:
 generating a radiofrequency energy by a radiofrequency generator; 
 controlling the radiofrequency generator by a control unit; 
 attaching a flexible pad having a surface area in a range of 1 cm 2  to 50 cm 2  to a body part of a patient during a treatment, wherein the flexible pad comprises:
 a flexible substrate comprising an underside configured to face the patient during the treatment; 
 an electrode having a surface area in a range of 1 cm 2  to 25 cm 2  coupled to the underside of the flexible substrate; and 
 an adhesive layer positioned below the electrode and configured to attach the electrode to the body part, 
 wherein a side of the electrode configured to face the body part is at least partially covered by the adhesive layer, and 
 wherein the electrode is configured to be in contact with the body part via the adhesive layer; and 
 
 applying the radiofrequency energy to the body part by the electrode to cause heating of the body part. 
 
     
     
       17. The method of  claim 16 , wherein the flexible pad further comprises a sticker configured to be coupled to a top side of the flexible substrate,
 wherein the sticker overlaps the flexible pad and has a dimension exceeding a corresponding dimension of the flexible pad in a range of 0.1 cm to 10 cm. 
 
     
     
       18. The method of  claim 17 , further comprising coupling the flexible pad to the body part by an adhesive positioned on a bottom side of the sticker overlapping the flexible pad. 
     
     
       19. The method of  claim 16 , wherein the adhesive layer covers the entire surface of the flexible pad facing the body area of the patient, and
 wherein the adhesive layer comprises an adhesive gel or adhesive tape. 
 
     
     
       20. The method of  claim 19 , wherein the adhesive layer has a thickness in a range of 0.1 mm to 3 mm. 
     
     
       21. The method of  claim 16 , further comprising:
 generating a pulsed electric current by an electric current generator; and 
 applying the pulsed electric current to the body part to provide an electrotherapy of the body part. 
 
     
     
       22. The method of  claim 21 , further comprising attaching the flexible pad to a forehead of the patient; and
 applying the pulsed electric current with a frequency in a range of 0.1 Hz to 300 Hz and a pulse duration in a range of 1 μs to 500 μs, wherein the pulsed electric current is configured to provide a relief of pain. 
 
     
     
       23. A device for a treatment of a patient, comprising:
 a radiofrequency generator configured to generate a radiofrequency energy; 
 a control unit configured to control the radiofrequency generator; and 
 an applicator configured to be coupled to a body part of a patient, the applicator comprising:
 a connector configured to couple the applicator with the radiofrequency generator; 
 a pad having a surface area in a range of 0.5 cm 2  to 100 cm 2  and configured to be attached to the body part during a treatment, the body part comprising a face, a neck, or a submentum, and the pad comprising:
 a flexible substrate comprising an underside configured to face the patient during the treatment; and 
 a flexible electrode coupled to the underside of the flexible substrate and configured to provide the radiofrequency energy to the body part to cause heating of the body part, the flexible electrode comprising:
 grid lines comprising a conductive material; 
 apertures separating the grid lines; and 
 a frame comprising the conductive material and defining a border of the grid lines and apertures; 
 
 
 a conductive lead configured to couple the flexible electrode with the connector; and 
 an adhesive layer positioned below the flexible electrode and configured to attach the pad to the body part, 
 wherein a side of the flexible electrode configured to face the body part is at least partially covered by the adhesive layer, and 
 wherein the flexible electrode is configured to be in contact with the body part via the adhesive layer. 
 
 
     
     
       24. The device of  claim 23 , wherein a thickness of the frame is in a range of 0.1 mm to 5 mm. 
     
     
       25. The device of  claim 23 , wherein a thickness of the grid lines is in a range of 0.01 mm to 2.3 mm. 
     
     
       26. The device of  claim 23 , wherein a total projected surface area of the frame, the grid lines inside the frame, and the apertures inside the frame is in a range of 1 cm 2  to 20 cm 2 . 
     
     
       27. The device of  claim 23 , wherein a distance between two closest parallel grid lines is in a range of 0.5 mm to 5 mm. 
     
     
       28. The device of  claim 23 , wherein a thickness of the frame is in a range of 0.1 mm to 5 mm,
 wherein a thickness of the grid lines is in a range of 0.01 mm to 2.3 mm, 
 wherein the thickness of the frame is thicker than the thickness of the grid lines, and 
 wherein the flexible electrode is printed by silver ink, silver-chloride ink, or graphite ink. 
 
     
     
       29. The device of  claim 23 , wherein a distance between the flexible electrode and an edge of the pad is in a range of 0.1 mm to 10 mm. 
     
     
       30. The device of  claim 23 , wherein the pad has a thickness in a range of 0.01 mm to 15 mm,
 wherein the pad is flexible with a stiffness in a range of shore OO10 to shore D80, and 
 wherein the flexible substrate comprises a polymer-based material, silicone based material, or fabric.

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